BIPHOZYL SOLUTION FOR HAEMODIALYSIS / HAEMOFILTRATION

SOLUTION, STERILE

**4.2 POSOLOGY AND METHOD OF ADMINISTRATION** **Posology** The volume and rate at which **Biphozyl** is administered depends on the blood concentration of phosphate and other electrolytes, acid–base balance, fluid balance and overall clinical condition of the patient. The volume of replacement solution and/or dialysate to be administered will also depend on the desired intensity (dose) of the treatment. Administration (dose, infusion rate and cumulative volume) of **Biphozyl** should only be established by a physician experienced in critical care medicine and CRRT (Continuous Renal Replacement Therapy). The range of flow rates when used as replacement solution in haemofiltration and haemodiafiltration are: Adult:500 – 3000 ml/h The range of flow rates when used as dialysate in continuous haemodialysis and continuous haemodiafiltration are: Adult:500 – 2500 ml/h Commonly used combined total flow rates for CRRT (dialysate and replacement solutions) in adults are approximately 2000 to 2500 ml/h which correspond to a daily fluid volume of approximately 48 to 60 l. Paediatric population In children from neonates to adolescents to 18 years, the range of flow rates used as substitution solution in haemofiltration and haemodiafiltration and as dialysis solution (dialysate) in continuous haemodialysis and continuous haemodiafiltration are 1000 to 4000 ml/h/1.73 m2. For adolescents (12–18 years), the adult dose recommendation should be used when the paediatric dose is calculated to exceed the maximum adult dose. Elderly patients Adults > 65 years of age: Evidence from clinical studies and experience suggests that use in the elderly population is not associated with differences in safety or effectiveness. **Method of administration** Intravenous use and use in haemodialysis. **Biphozyl** solution, when used as a replacement solution, is administered into the extracorporeal circuit before (pre-dilution) or after (post-dilution) the haemofilter or haemodiafilter. **Biphozyl** solution, when used as a dialysate, it is administered in the dialysate compartment of the extracorporeal filter separated from the blood flow by a semipermeable membrane. For instructions on reconstitution of the medicinal product before administration, see section 6.6 (Special precautions for disposal and other handling) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.